Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis.

ABSTRACT: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We characterized tofacitinib pharmacokinetics in patients with moderate to severe UC, and the effects of covariates on variability in pharmacokinetic parameter estimates. Data were pooled from 1 8-week phase 2 and 2 8-week phase 3 induction studies, and a 52-week phase 3 maintenance study (N = 1096). Population pharmacokinetic analysis was conducted using nonlinear mixed-effects modeling. Potential predictors of apparent oral clearance (CL/F) and volume of distribution (V/F) were evaluated. The PK was described by a 1-compartment model parameterized in terms of CL/F (26.3 L/hour [h]) and V/F (115.8 L), with first-order absorption (K_a ; 9.85 h^-1 ) and lag time (0

SUBMITTER: Vong C 

PROVIDER: S-EPMC7986169 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature